MAUDE Adverse Event Report: BIOTRONIK RV LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number LINOXSD

Device Problems High impedance (1291); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The svc coil impedance alert sounded last wednesday.The impedance was stable around ~100 ohms but suddenly increased to >130 ohm.The rv coil impedance is good and stable, so therefore it could be considered to program to a single coil configuration.Physician indicated that patient had no shocks since implant so agrees with single coil configuration.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17488119
• MDR Text Key: 320696574
• Report Number: MW5120842
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: LINOXSD
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1